Product Classification

• Device: oximeter, infrared, sporting, aviation
• Regulation Description: Oximeter.
• Definition: Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
• Physical State: sports watch that emits infrared
• Technical Method: Non-invasive infrared
• Target Area: Circulatory pulse
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: OCH
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: Enforcement Discretion
• Regulation Number: 870.2700
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible